PharmaSynth takes pride in providing a quality manufacturing service to an international standard. PharmaSynth has a total quality assurance system developed and inspected in accordance with local and international requirements. Visit: http://www.pharmasynth.com.au/

1. Quality in Contract Biomanufacturing
PharmaSynth services are bound by our team’s commitment to offering the best solution for the client.
Our team finds innovative ways of solving problems. We do this by utilizing our extensive experience
in development of cGMP manufacturing process and subsequent production.
PharmaSynth takes pride in providing a quality manufacturing service to an international standard.
PharmaSynth has a total quality assurance system developed and inspected in accordance with local
and international requirements.
The PharmaSynth facility follows the international GMP guidelines as setout in the (PIC/S) “Guide to
Good Manufacturing Practice for Medicinal Products Part II (PIC/S 009-8). Australia is also a founding
member state of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resulting in Australian
Therapeutics Goods Administration (TGA) guidelines being adopted internationally. As such our TGA
license indicated that we follow the International Conference on Harmonisation (ICH) Technical
Requirements for the Registration of Pharmaceuticals for Human Use and our TGA license is
recognized by other PIC/S member countries. Also our facility is audited routinely by the TGA and by
our clients as part of their due diligence and regulatory compliance.
Besides a license from the TGA for the manufacture of human therapeutic API’s (active
pharmaceutical ingredients) from biological and synthetic sources, the PharmaSynth facility also has
the following licences:

APVMA (Veterinary equivalent of the TGA) licence for manufacture of sterile immunobiological
products.

OGTR licence for the production of products from genetically modified organisms.

AQIS facility licence for import and use of biologic materials.
According to the TGA (Australia's Therapeutic Goods Administration) and ICH Guidelines, key quality
management principles are:

Quality should be the responsibility of all persons involved in manufacturing.

Each manufacturer should establish, document, and implement an effective system for
managing quality that involves the active participation of management and appropriate
manufacturing personnel.

The system for managing quality should encompass the organisational structure, procedures,
processes and resources, as well as activities necessary to ensure confidence that the API
will meet its intended specifications for quality and purity. All quality related activities should
be defined and documented.

2. 
There should be a quality unit(s) that is independent of production and that fulfils both quality
assurance (QA) and quality control (QC) responsibilities. This can be in the form of separate
QA and QC units or a single individual or group, depending upon the size and structure of the
organization.

The persons authorised to release intermediates and APIs should be specified.

All quality related activities should be recorded at the time they are performed.

Any deviation from established procedures should be documented and explained. Critical
deviations should be investigated, and the investigation and its conclusions should be
documented.

No materials should be released or used before the satisfactory completion of evaluation by
the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g.
release under quarantine as described in Section 10.20 or the use of raw materials or
intermediates pending completion of evaluation).

Procedures should exist for notifying responsible management in a timely manner of
regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g.
quality related complaints, recalls, regulatory actions, etc.).
With the above guidelines and internationally recognized licenses in place, PharmaSynth offers our
clients the confidence that their product is being manufactured under the most appropriate conditions.
You can also be assured that PharmaSynth offers the most up to date practices because our scientist
not only get the job done but also show initiative such as offering suggestions for improving
processes.
PharmaSynth's quality unit is staffed with individuals that also understand processes. We therefore
are capable of identifying critical quality parameters (CPPs) and key performance indicators (KPIs),
and employ real-time monitoring and controls across the manufacturing process.
Contact Us
Email: enquiries@pharmasynth.com.au
Website: http://www.pharmasynth.com.au/